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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CFN MEXICO 215 SA DE CV AS LVP 20D 2SS CV INTRAVASCULAR ADMINISTRATION SET

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CFN MEXICO 215 SA DE CV AS LVP 20D 2SS CV INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 2420-0007
Device Problem Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 06/10/2020
Event Type  Malfunction  
Manufacturer Narrative

Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.

 
Event Description

It was reported that a hole was found in the as lvp 20d 2ss cv tubing. The following information was provided by the initial reporter: "another set, same lot, had a hole. ".

 
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Brand NameAS LVP 20D 2SS CV
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
CFN MEXICO 215 SA DE CV
parque industrial el florido.
tijuana, null 22244
MX 22244
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 s state st
sandy UT 84070 3213
Manufacturer Contact
brett wilko
9450 s state st
sandy, UT 84070-3213
8015652341
MDR Report Key10216198
MDR Text Key198086659
Report Number9616066-2020-01996
Device Sequence Number1
Product Code FPA
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER,USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL Number2420-0007
Device Catalogue Number2420-0007
Device LOT Number20033183
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/16/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/10/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/30/2020 Patient Sequence Number: 1
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